Cereno Scientific publishes year-end report for 2022 (1 January – 31 December)

The Board and Chief Executive Officer of Cereno Scientific AB here presents the year-end report for the year 2022.

Summary of the year-end report, January – December 2022

Cereno Scientific Group

Full year (1 January – 31 December 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -27,648,649 (-16,250,680)
• Earnings per share was SEK -0.20 (-0.15) before dilution and SEK -0.19 (-0.11) after dilution
• The equity/assets ratio was 93.4% (94.1%)
• Cash and bank balance was SEK 67,045,679 (89,634,757)

Fourth quarter (1 October – 31 December 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -8,635,283 (-4,233,513)
• Earnings per share was SEK -0.06 (-0.04) before dilution and SEK -0.06 (-0.03) after dilution

Parent company

Full year (1 January – 31 December 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -27,747,301 (-16,576,604)
• Earnings per share was SEK -0.20 (-0.16) before dilution and SEK -0.19 (-0.12) after dilution
• The equity/assets ratio was 93.5% (94.1%)
• Cash and bank balance was SEK 67,012,503 (89,594,519)

Fourth quarter (1 October – 31 December 2022)

• Net sales were SEK 0 (0)
• Result after financial items was SEK -8,536,630 (-4,401,536)
• Earnings per share was SEK -0.06 (-0.04) before dilution and SEK -0.06 (-0.03) after dilution

Significant events during the fourth quarter

• In mid-October, Cereno expanded patent protection for drug candidate CS1 through its second patent family by obtaining patents in Israel and in Malaysia.
• In October, a loan of 5 MSEK was amortized according to the terms. This is the second and last installment on the loan from 2020.
• In November, the Nomination Committee was present­ed consisting of the following members: Cihan Punar, representing the Company's largest group of sharehold­ers (per May 31, 2022); Sverker Jern, representing the Company's founders and Catharina Bäärnhielm, conven­ing member and Chair of the Board of Cereno.
• Early December, Cereno participated at the 19th Global Cardiovascular Clinical Trialists (CVCT) Forum 2022, in Washington D.C., US, discussing clinical trials in cardi­ovascular disease with top thought leaders. The Forum brings together the top thought leaders in cardiovas­cular clinical trials and is co-chaired by Dr Bertram Pitt and Dr Faiez Zannad, both part of Cereno’ Scientific Advisory Board. Cereno’s Chief Medical Officer (CMO), Dr. Björn Dahlöf, was invited to speak and participate in several program sessions providing an industry per­spective on significant topics such as patient benefit, clinical outcomes and trial design in both thrombosis and PAH, including the innovative design of the CS1-PAH Phase II trial.

Significant events after end of period

• In January, it was announced that an abstract on pre­clinical drug candidate CS585 had been accepted as a moderated poster presentation at ACC.23/WCC. The scientific congress is hosted by the American College of Cardiology Together With WCC (World Congress of Cardiology), in New Orleans, US, on March 4-6, 2023. The abstract titled “CS585 is a novel orally available prostacyclin receptor agonist with long-term in vivo in­hibition of platelets and thrombosis formation in mouse without increased risk of bleeding” will be presented by Dr. Michael Holinstat, lead of Cereno’s development programs at the University of Michigan and Director of Translational Research at Cereno.
• At the end of January, the company announced the ap­pointment of Etienne Adriansen to the newly created position as Chief Business Officer, as of March 1, 2023.This appointment adds commercial expertise and capac­ity to Cereno's Executive Management Team as business development is an active and important component of the company’s growth strategy.
• In early February, Cereno launched an Insights Series providing a unique view into different aspects of car­diovascular disease treatment landscape through in­terviews and conversations with Cereno’s leadership, collaborative partners, and global thought leaders. The videos were mainly recorded in conjunction with the European Society of Cardiology (ESC) Congress in Barcelona late August 2022, and are centered around PAH and thrombosis.
• In February, Cereno announced the progress with its CS1 Phase II trial in PAH. All 9 clinical sites have been activated and the protocol changed to broader patient inclusion criteria and three patients were reported to be randomized and have entered the treatment period. Top-line results are expected end of 2023.
• In February it was announced that Cereno’s preclini­cal drug candidate CS014 will continue toward clinical development for thrombosis prevention. CS014 has, in preclinical studies, demonstrated anti-thrombotic prop­erties without bleeding, supporting the selection of target indication with the aim of preventing thrombosis. The drug candidate is currently in the final stages of its preclinical development program, and a Phase I study is expected to start in 2024.

Letter from the CEO

During the fourth quarter of 2022, the Cereno team was working with high intensity on the many activities driving the delivery of our business strategy to achieve milestones related to our growth plan. We started 2023 with an expanded team, having appointed key competence to the Executive Management Team, well prepared and equipped to continue our quest to develop innovative treatments for patients with significant unmet medical needs.

Progressing Phase II study of CS1 in PAH

Our drug candidate CS1, with its unique efficacy profile, has the potential to offer a safe, efficacious, and disease-mod­ifying treatment option for patients suffering from the severe rare disease PAH. The ongoing Phase II study in PAH is progressing well. The last few months have been filled with intensive activities trying to activate centers and im­plement different measures to simplify and increase patient recruitment. I am happy that we are now beginning to see the real impact of these initiatives. All nine clinical sites are now activated and actively recruiting patients; three pa­tients have been randomized and entered the treatment period. The amended study protocol was well received by the investigators, and we are now seeing a significant increase in the number of patients identified for screening for potential inclusion in the study. According to the now updated plan, we expect to complete the study end of 2023 and share top-line results thereafter.

I am also pleased to comment on the obtained patents in Israel and in Malaysia, respectively, in CS1’s second patent family, as was announced in the last quarter. This strength­ens and broadens the intellectual property rights of CS1 and is an important aspect of preparing the future com­mercial positioning, together with a strong clinical data set.

Preclinical drug candidate CS014 to prevent thrombosis

We recently announced that we have decided to initially focus our clinical development of CS014 as a treatment for the prevention of thrombosis. This is a significant step for­ward as we prepare for the upcoming clinical stage. There is a great medical need for effective antithrombotic therapy with less bleeding problems in the prevention of throm­bosis. This very large and growing market is estimated to reach about USD 70 billion by 2030 and signifies a very large business potential for new therapies that can meet this need. It is thus very exciting for Cereno to have a candi­date drug, CS014, which has shown efficacy in preventing thrombosis without increased risk of bleeding in preclini­cal models. If we are able to obtain similar data in clinical studies, we have a fantastic potential to deliver a disruptive new therapy to the market that will meet a great unmet medical need for millions of patients. The CS014 program is currently in its later stages of mandatory toxicological studies with preparations for first-in-man clinical studies ongoing in parallel. If all goes according to plan, we will be looking forward to starting a Phase I study with CS014 in the first half of 2024.

Further strengthening of intellectual property position for CS1

During the fourth quarter we again further expanded our patent protection of CS1. This time with the first patent to be granted in the third patent family for CS1 for the Russian market. In January we added the second patent to the third patent family, this time in one of the world’s largest pharmaceutical markets, Japan. We now have patents granted across all three patent families for CS1 covering Australia, Canada, Japan, Russia, Europe, and the US. Protecting our innovations is an important element in our efforts to optimize the commercial positioning of our portfolio pipeline and I am therefore very pleased with the work that is being done in this area.

Preclinical development of CS585

Our candidate drug CS585 is currently in a 24-month pre­clinical development program in collaboration with the University of Michigan. We are actively sharing new preclin­ical data obtained on CS585 at scientific congresses, and Dr. Michael Holinstat, lead of the program at the University of Michigan and Director Translational Research at Cereno, will in early March present at the ACC.23/WCC hosted by the American College of Cardiology together with WCC (World Congress of Cardiology), in New Orleans, US. The abstract titled “CS585 is a novel orally available prostacyclin receptor agonist with long-term in vivo inhibition of plate­lets and thrombosis formation in mouse without increased risk of bleeding,” will be presented as a moderated poster.

Making waves in the scientific community

We have increased our scientific communication activities significantly during 2022 as our three drug development programs are progressing and we have seen positive effects from these efforts. In the last quarter, Cereno’s CMO Björn Dahlöf was in Washington D.C. attending the by invita­tion-only annual educational meeting Global Cardiovascular Clinical Trialists (CVCT) Forum. The CVCT is an important arena to continue to build relationships with academia, reg­ulatory representatives, investigators, and patients as well as sharing the stage with industry pharma majors.

In 2023, we will continue to increase awareness of the company by being present at several of the key scientific congresses throughout the year to present data from our preclinical development programs and continue to show­case our innovative clinical study with CS1 in PAH, which has gained attention already at scientific events last year.

In February we launched our “Insights Series”, a video series providing insights into cardiovascular disease and our study program addressing thrombosis and PAH, through interviews and conversations with Cereno’s leadership, collaborating partners and global thought leaders. I am very pleased by how well the videos showcase the deep expertise linked to Cereno and would like to encourage you watch them to get a better understanding of our vision and how we pursue it with some of the best scientists in the field of cardiovascular disease. Videos from the Insights Series will be released during 2023 and can be found on our website.

Growing the organization

At the end of the quarter, our Chief Medical Officer also stepped into the roles Chief Scientific Officer (CSO) and Head of Clinical Development allowing Cereno’s R&D to be progressed with a strong drive forward. I am, also, very pleased to have added other key competencies on the busi­ness development and communication side.

Outlook

2023 is set to be a significant year for Cereno with the com­pletion of the Phase II study with CS1 and the preclinical development activities to prepare for Phase I studies with CS014. The team is diligently working according to our strategy and development plan objectives while keeping appraised of any potential impact of the geopolitical un­certainties that are still very much present in society.

I look forward to the many milestones ahead delivering on our commitment to developing innovative treatments for common and rare cardiovascular disease where great unmet medical needs exist.

February 2023

Sten R. Sörensen
CEO, Cereno Scientific

Financial calendar

Annual report 2022   6 April 2023

Interim report Q1   17 May 2023

Annual general meeting   1 June 2023

Interim report Q2   25 August 2023

Interim report Q3   17 November 2023

For further information, please contact:

Josefine Göranson, Head of IR & Communication
Phone: +46 704 92 35 63
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/

About Cereno Scientific AB

Cereno Scientific is a clinical-stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH). CS1 is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties, all relevant for PAH. A clinical Phase II study is ongoing to evaluate CS1’s safety, tolerability, and efficacy in patients with PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Cereno also has two promising preclinical drug candidates in development for cardiovascular disease through research collaborations with the University of Michigan. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects, selected for prevention of thrombosis as target indication. In preclinical studies, it has been documented to regulate platelet activity, fibrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. Thrombosis prevention in venous or arterial and cardiovascular disease has been selected as the first indication area for CS014. Drug candidate CS585 is a stable, selective, and potent prostacyclin receptor agonist. It has been documented in preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding. The company is headquartered in Gothenburg, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.